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Title: Reduced exposure to calcineurin inhibitors in renal transplantation
Author: Ekberg, Henrik
Tedesco-Silva, Helio
Demirbas, Alper
Vitko, Stefan
Nashan, Björn
Gürkan, Alp
Margreiter, Raimund
Hugo, Christian
Grinyó Boira, Josep M.
Frei, Ulrich
Vanrenterghem, Yves
Daloze, Pierre
Halloran, Philip F.
Keywords: Corticosteroides
Ús terapèutic
Inhibidors enzimàtics
Rebuig (Biologia)
Trasplantament renal
Adrenocortical hormones
Therapeutic use
Enzyme inhibitors
Graft rejection
Immunosupressive agents
Kidney transplantation
Issue Date: 20-Dec-2007
Publisher: Massachusetts Medical Society
Abstract: Background: immunosuppressive regimens with the fewest possible toxic effects are desirable for transplant recipients. This study evaluated the efficacy and relative toxic effects of four immunosuppressive regimens. Methods: we randomly assigned 1645 renal-transplant recipients to receive standard-dose cyclosporine, mycophenolate mofetil, and corticosteroids, or daclizumab induction, mycophenolate mofetil, and corticosteroids in combination with low-dose cyclosporine, low-dose tacrolimus, or low-dose sirolimus. The primary end point was the estimated glomerular filtration rate (GFR), as calculated by the Cockcroft-Gault formula, 12 months after transplantation. Secondary end points included acute rejection and allograft survival. Results: the mean calculated GFR was higher in patients receiving low-dose tacrolimus (65.4 ml per minute) than in the other three groups (range, 56.7 to 59.4 ml per minute). The rate of biopsy-proven acute rejection was lower in patients receiving low-dose tacrolimus (12.3%) than in those receiving standard-dose cyclosporine (25.8%), low-dose cyclosporine (24.0%), or low-dose sirolimus (37.2%). Allograft survival differed significantly among the four groups (P=0.02) and was highest in the low-dose tacrolimus group (94.2%), followed by the low-dose cyclosporine group (93.1%), the standard-dose cyclosporine group (89.3%), and the low-dose sirolimus group (89.3%). Serious adverse events were more common in the low-dose sirolimus group than in the other groups (53.2% vs. a range of 43.4 to 44.3%), although a similar proportion of patients in each group had at least one adverse event during treatment (86.3 to 90.5%). Conclusions: a regimen of daclizumab, mycophenolate mofetil, and corticosteroids in combination with low-dose tacrolimus may be advantageous for renal function, allograft survival, and acute rejection rates, as compared with regimens containing daclizumab induction plus either low-dose cyclosporine or low-dose sirolimus or with standard-dose cyclosporine without induction.
Note: Reproducció del document publicat a:
It is part of: New England Journal of Medicine, 2007, vol. 357, num. 25, p. 2562-2575
Related resource:
ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)

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